When Doctors Can't Wait
By Gina Shaw
Jan. 15, 2001 -- When Naomi Williams' first child, Julian, was born in 1996, at first he seemed the picture of health. But as she and her husband Dan fussed over their newborn in the recovery room, Julian began to seem lethargic and threw up some clear liquid. His temperature dropped steadily despite skin-to-skin contact and heated blankets.
Then -- less than six hours after he was born -- the Williamses watched helplessly as Julian was whisked from his mother's arms into the neonatal intensive care unit. Doctors at the San Francisco hospital feared a blood-borne infectious condition called neonatal sepsis, which can swiftly progress in infants to cause death.
The next time Naomi Williams saw her son, he lay in an incubator under 24-hour observation, hooked to an intimidating array of machines that provided, among other things, intravenous antibiotics.
You may never have heard of neonatal sepsis, a worldwide killer that's comparatively uncommon in the U.S. because it's easily treated with antibiotics. But every year, according to government estimates, 300,000 American newborns are rushed into intensive care, stuck with an IV, and placed amid a tangle of monitors for anywhere from 24 hours to a week or more, because doctors fear they have sepsis.
In fact, according to the same estimates, only one in 17 infants treated for sepsis actually has it. The problem: The best test currently available is a blood culture that takes days to accurately diagnose sepsis, while the infectious condition can kill an infant within hours. Doctors can't afford to wait.
Now a new blood test being clinically evaluated could spare the anguish for the vast majority of such families -- and at least some of the estimated $800 million in annual treatment costs. The Williams family, fully insured, racked up $15,000 in intensive-care charges for Julian. "What if we hadn't had insurance, or had been underinsured?" wonders Naomi Williams.
The new test, originally developed by a team of researchers at Stanford University and licensed to Massachusetts-based CompuCyte Corp., could provide a definitive diagnosis of sepsis in less than 20 minutes. It works by measuring inflammation in white blood cells. "There are very few conditions in which an infant at birth, or shortly after birth, shows evidence of overwhelming inflammation. The white blood cells are very sensitive to infection, and the body's reaction is to turn those on as the first line of defense to kill bacteria," says Timothy Holzer, PhD, CompuCyte's vice president for biomedical development.
The test is being studied in two separate trials, one at Boston University Medical Center and one at the University of Massachusetts Medical Center. If all goes well, Holzer hopes to submit the results of these studies to the U.S. Food and Drug Administration by the end of 2001. If the FDA approves the test, the earliest it could be available commercially would be mid-2002.
Results for the new test so far have been very promising, says Alan Michelson, MD, professor of pediatrics and pathology at the University of Massachusetts Medical School. "A test that could rapidly tell you whether or not an infant is septic would save families a lot of trauma and a lot of money," says Michelson, who isn't directly involved in the trials of the sepsis test, but does other research involving CompuCyte. "There are a lot of babies who wouldn't need intensive care treatment."
Naomi Williams couldn't agree more. After eight days of anguish -- some spent sleeping in an unused recovery room in the hospital, some at home without her newborn son -- she came closer to a breakdown than she'd ever thought possible. At last, the couple was able to bring home a vigorous, healthy Julian. But they still don't know if he ever had sepsis. Williams is grateful to the hospital for the care they provided, and she knows it may well have saved her son's life. Still, "this was the most traumatic experience of our lives. But was it really necessary?" she wonders. "Wouldn't it be great if you could find out sooner?"
"Everybody's still looking for the magic wand," says Charles R. Rosenfeld, MD, director of the Division of Neonatal-Perinatal Medicine at the University of Texas Southwestern Medical Center in Dallas. "It must permit you to have very high specificity -- that is, few false negatives -- and very high sensitivity, which would be few false positives." While not familiar with the CompuCyte test, Rosenfeld cautions that even with a 20-minute result, physicians still will be inclined to begin treatment immediately. "You're still going to end up treating these kids in the first 24 hours. Nobody in his right mind is going to wait for a test to come back -- no matter how quickly -- if you think the baby's infected," he says.
Holzer agrees that doctors will, and should, proceed with caution. "I think there will have to be very compelling data before clinicians will change their practice," he says. "If they still feel, in their clinical experience, that this infant is potentially septic, they'll go ahead and treat. But the new test may allow them to have some confidence to not treat certain babies, or to discontinue therapy sooner."
That alone would have been a godsend for Naomi Williams, who struggled with breastfeeding an infant hooked up to machines and slept little, if at all, throughout the eight days Julian was in intensive care. "When you're in the hospital with this little helpless child that you've given birth to, the fear is just awful," she says. "If we could have known sooner, it would have been wonderful."
Gina Shaw is a Washington-based freelance writer who writes frequently about health and medicine.
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